FDA approves Bristol-Myers Squibb’s Orencia for active psoriatic arthritis


The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Orencia for the treatment of adult patients with active psoriatic arthritis (PsA).

PsA is a chronic, inflammatory disease in which the immune system attacks healthy joints and skin.

The disease affects a person's skin and musculoskeletal system, causing joint pain, stiffness and reduced range of motion.

The treatment is approved and available in intravenous (IV) and subcutaneous (SC) injection formulations.

Bristol-Myers Squibb Orencia development lead and vice-president Brian Gavin said: “This approval underscores the efficacy of Orencia in adult patients with active PsA, who have been in need of new treatments.

"This approval underscores the efficacy of Orencia in adult patients with active PsA, who have been in need of new treatments."

“Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce Orencia, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”

The co-stimulation blockade of the treatment inhibits T-cell activation and the resulting series of events that lead to inflammation. T-cell activation is involved in the pathogenesis of PsA.

The FDA approval was based on results from two randomised, double-blind, placebo-controlled trials, PsA-I and PsA-II.

The studies demonstrated that Orencia can improve or reduce disease activity in both TNF-naive and exposed patients with high-disease activity, a high level of tender and swollen joints, and a disease duration of more than seven years.

The safety profile of the treatment was comparable between studies PsA-I and PsA-II and consistent with the safety profile in RA.

Orencia is not recommended to be used concomitantly with TNF antagonists and other biologic Rheumatoid Arthritis (RA) therapy, such as anakinra.